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Latuda Approval History

  • FDA approved: Yes (First approved October 28th, 2010)
  • Brand name: Latuda
  • Generic name: lurasidone
  • Dosage form: Tablets
  • Company: Dainippon Sumitomo Pharma America, Inc.
  • Treatment for: Schizophrenia, Bipolar Disorder

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

Development History and FDA Approval Process for Latuda

DateArticle
Jan 28, 2017Approval Sunovion’s Latuda (lurasidone) Receives FDA Approval to Treat Adolescents with Schizophrenia
Jul  1, 2013Approval Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
Oct 28, 2010Approval FDA approves Latuda to treat schizophrenia in adults
Mar 10, 2010Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia
Jan  6, 2010Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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